View clinical trials related to Hepatitis B.
Filter by:To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy
The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.
The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine will be well-tolerated and induce hepatitis B virus (HBV)-specific virological and immunological responses in chronic hepatitis B (CHB) patients.
The presence of persistent inadequate or suboptimal virologic response is a strong risk factor for viral resistance and breakthrough and also for disease progression of chronic hepatitis B, and thus, a change in therapy is required. The combination of entecavir (ETV) and adefovir (ADV) is a promising treatment for patients with lamivudine (LAM)-resistance who show suboptimal response to the combination of LAM and ADV. In this randomized, open labeled trial,the investigators will compare the efficacy of continuation of ADV plus LAM versus switch to ADV plus ETV in adults with LAM-resistant chronic hepatitis B who shows suboptimal response to the combination treatment of ADV and LAM.
To demonstrate the dose response of entecavir in Japanese patients as measured by HBV DNA levels by PCR (log10 copies/mL) at Week 22
The objectives of this study are to demonstrate that entecavir has antiviral activity with undetectable at Week 48, and to assess the safety and the pharmacokinetic in Japanese patients given entecavir at each dose of 0.1 and 0.5 mg for 52 weeks
Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide with an estimated 626,000 new cases per year worldwide, accounting for 5.7% of new cancer cases. Although resection and transplantation offer the best 5-year survival rates, not all patients are suitable surgery candidates. Other treatments include pericutaneous ethanol injection (PEI), radiofrequency ablation (RFA), and transarterial oily chemoembolization (TOCE), all of which enhance the survival rate and aid in shrinkage of the tumor. The very low survival rate among HCC patients, 3-5%, reflects the inadequacy of conventional therapies for the disease and highlights the necessity of finding new treatments or modifying the current treatment. The hepatitis B virus (HBV) causes liver disease that can range in severity from a mild illness that lasts several weeks (acute hepatitis B) to a long-term chronic illness. An estimated 2 billion people have been infected with HBV worldwide, resulting in more than 350 million individuals with chronic, long-term liver infections. Patients with chronic HBV infection are at a great risk for the development of cirrhosis, hepatic failure, and HCC. There is no cure for hepatitis B and care is mostly palliative. There are several anti-viral and interferon drugs, such as Entecavir and Interferon α therapy, which can help some patients. However, these drugs are costly, thousands of dollars per year, and are not widely available in many countries, especially in the developing world. Vaccination is available and effective and is recommended for all individuals at risk for HBV infection. However, vaccination is only effective in individuals who have not been exposed to HBV. Hepatitis B is closely linked to liver cancer, which is almost always fatal. MGN-3/Biobran is an arabinoxylan extracted from rice bran that is treated enzymatically with an extract from Shiitake mushrooms. MGN-3 demonstrated anti-cancer activity in vivo in mice and humans. The present study was carried out to examine whether combining the current conventional treatment with a food supplement, arabinoxylan rice bran (MGN-3/Biobran), may improve the outcome of the disease and increase the survival rate of patients with HCC or HBV. We hypothesize that a combinatory treatment of conventional therapy with MGN-3/Biobran will augment the therapeutic effect seen when patients are treated with conventional therapy alone.
This observational, non-interventional cohort study will evaluate predictors of response in patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and safety parameters will also be evaluated. Patients included in the study will be followed for the duration of their treatment and for up to 3 years thereafter.
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
This study will evaluate the persistence of the immune response to HAV (Hepatitis A Virus) antigens and HBs (Hepatitis B surface) antigens in healthy adults previously vaccinated with GlaxoSmithKline (GSK) Biologicals' Twinrix Adult. The subjects will be invited for blood sampling 16, 17, 18, 19 and 20 years after vaccination to evaluate the antibody persistence. For subjects in whom low circulating antibodies are detected, the presence of immune memory against hepatitis A & B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine (Havrix and/or Engerix-B) at the next planned visit. No new subjects will be recruited during this study.